Cryotherapy With or Without Short-term Adjuvant Androgen-Deprivation Therapy for High-Risk Localized Prostate Cancer — Open-Label Randomized Clinical Study
Subjects (N=182) who have high-risk prostate cancer and have undergone primary prostate
cryotherapy will be screened and randomized in a 1:1 ratio to receive either adjuvant ADT
(Adj-ADT) or No-ADT until disease progression. Screening and randomization will be done
within four weeks after cryoablation. Only those who are assigned to Adj-ADT will receive
ADT for a total of 12 months. PSA will be checked every 3 months in the first year after
Cryo and every 6 months thereafter. Long-term follow-up parameters include serum PSA and
protocol-mandated biopsies (at 36 months after Cryo, irrespective of PSA levels if
recurrence has not been documented). For-cause biopsy will also be done if post-Cryo PSA
elevation reaches the Phoenix criteria (Nadir + 2 ng/ml) or when the treating physician
thinks it necessary to document tumor recurrence.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
A composite trifecta endpoint of treatment failure at 3 years after cryoablation
A composite trifecta endpoint of treatment failure at 3 years after cryoablation defined by either of the three, biochemical (PSA) recurrence (by the Phoenix criteria) or biopsy-proven recurrence or initiation of hormone therapy for disease recurrence whichever comes first.
3 years
No
Yeong-Shiau Pu, MD, PhD
Principal Investigator
National Taiwan University Hospital
Taiwan: Department of Health
201103057MB
NCT01398657
July 2011
June 2016
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